Prince Joseph

Experience

• 

  Reliance Life Sciences Pvt. Ltd.

  Nov 2006 - Feb 2010

  Production Executive

  1. Organized & planned daily Production targets & achieving them in the stipulated time. Manufactured sterile products as per master formula record. Supervised the daily Production activities with adhering to quality standards, cGMP. 2. Executed the aseptic filling activities in Grade an area (SVPs / LVPs / lyophilized products). Complied to all approved procedures, documents and GMP activities during production.3. Performed all the assigned production activities in confirmation to Batch record and recorded the details in record sheet and logbooks. Observe abnormalities or deviations are observed, recorded and inform to the production in charge to avoid any quality issues in the product. Show less

• 

  Tata Consultancy Services

  Feb 2010 - Nov 2018

  1. Provided updates for Data Management during internal /client team meetings and communication if required, metric reports for internal/external project teams 2. Reviewed data management documentation including the Data Management Plan, Data Review Plan, eCRF Completion Guidelines, and others as needed, supported design and testing of EDC study designs3. Created listings/reports using ad hoc reporting tools across multiple EDC systems, communicate project risks or possible quality issues.4. Performed data management activities such as data review, serious adverse event reconciliation, third party electronic data (e.g. laboratory, PK, diary) reconciliation, and query management, reviewed query responses with the highest level of quality. Show less To be aware and to undertake any relevant and applicable training around client SOPs, GUI and data standards.To demonstrate understanding of study protocol, study tasks/activities and study milestones.Provide input to study Set-Up, Conduct and close out study documents like Electronic Case Report Form (eCRF) Completion guidelines, Data Management Plan (DMP), Protocol Deviation Management Plan (PDMP), Investigator/Monitor meeting materials.Review Data Validation Specifications (DVS), eCRF screens and test scripts for edit/SAS checks, create test scripts for UAT and other activities as agreed in Data Processing Plan (DPP).To perform Data review and discrepancy management as per DPP or as agreed with the study data manager.To process, perform data load and delivery of external (vendor) data using designated client tools.To perform external (vendor) data reconciliation at agreed frequency in order to maintain consistency with the clinical database (e.g. InForm).To escalate unresolved data discrepancies / data trends to study data manager.To coordinate with programming team as appropriate regarding any database or for programming changes needed throughout the study.To address & action data issues highlighted by study team as and when required.To create and distribute Data Management metrics/Newsletter, listings and reports at an agreed frequency with Study data manager.To conduct regular scheduled study meeting with study data manager and to ensure timely documentation of study decisions.To connect with vendor & monitor for addressing issues as agreed in Data Processing Plan.Will work with Study data manager on study close-out activities referring DBR checklist and using tools as appropriate.Perform Post Database Release (DBR) activities & Pre-Database Freeze (DBF) activities as required based on discussion/agreement with study data manager to ensure quality data delivery.To maintain in-stream archival of relevant study documents in eTMF. Show less To be aware and to undertake any relevant and applicable training around client SOPs, GUI and data standards.To demonstrate understanding of study protocol, study tasks/activities and study milestones.Provide input to study Set-Up, Conduct and close out study documents like Electronic Case Report Form (eCRF) Completion guidelines, Data Management Plan (DMP), Protocol Deviation Management Plan (PDMP), Investigator/Monitor meeting materials.Review Data Validation Specifications (DVS), eCRF screens and test scripts for edit/SAS checks, create test scripts for UAT and other activities as agreed in Data Processing Plan (DPP).To perform Data review and discrepancy management as per DPP or as agreed with the study data manager.To process, perform data load and delivery of external (vendor) data using designated client tools.To perform external (vendor) data reconciliation at agreed frequency in order to maintain consistency with the clinical database (e.g. InForm).To escalate unresolved data discrepancies / data trends to study data manager.To coordinate with programming team as appropriate regarding any database or for programming changes needed throughout the study.To address & action data issues highlighted by study team as and when required.To create and distribute Data Management metrics/Newsletter, listings and reports at an agreed frequency with Study data manager.To conduct regular scheduled study meeting with study data manager and to ensure timely documentation of study decisions.To connect with vendor & monitor for addressing issues as agreed in Data Processing Plan.Will work with Study data manager on study close-out activities referring DBR checklist and using tools as appropriate.Perform Post Database Release (DBR) activities & Pre-Database Freeze (DBF) activities as required based on discussion/agreement with study data manager to ensure quality data delivery.To maintain in-stream archival of relevant study documents in eTMF. Show less

  • Assistant Manager

    Sept 2017 - Nov 2018

  • Business Process Lead

    Jan 2014 - Sept 2017

  • Senior Process Associate

    Feb 2010 - Dec 2013
• 

  ICON plc

  Nov 2018 - Dec 2021

  Clinical Data Lead

  1. Led all facets of clinical data management related tasks for multiple studies across therapeutic areas such as inputs into protocols, execution of Study Specification Worksheet (SSW), select and audit CROs, ensured quality and timely completion of data operations deliverables meeting KPIs and proactively maintaining documents audit-ready by timely archival of data operation documents into document management systems.2. Developed and presented CDM activities in investigator meetings, CRA workshops, and Project Kick-off meetings as appropriate.3. Ensured complete and consistent medical term coding in collaboration with medical teams using appropriate standard dictionaries; ensure consistency of serious adverse events data across clinical and drug safety databases.4. Ensured up-to-date and accurate tracking of study status, proactively identify and mitigate risks. Escalate risks and challenges as appropriate.5. Supported biometrics leadership to Initiate, drive and implement innovative digital strategies, develop of analytical dashboards across clinical studies in coordination with internal and external stakeholders.6. Successfully implemented Portfolio Clean Patient Tracker (CPT). Show less

• 

  Cognizant

  Dec 2021 - Mar 2023

  Team Manager

  1. Interacting with Client/Customer to manage and resolve customer requests and escalations through effective communication, negotiation skills and prioritization.2. Providing project updates and maintaining performance metrics, generating periodic reports for client report meetings.3. Reviewing internal reports need to see customization as per client and corporate demands, ensuring integrity and quality of data presented to the client. Acting as an SME for the team to Identify & resolve issues and document all process changes4. Monitoring & reviewing first level processing, Process complex Transactions, Handling first level escalations from the client, Identifying and assessing service improvement opportunities and Contribute to process improvement initiatives.5. Performing quality checks/audits to ensure data integrity, error-free processing & identification of risks, Identifying and reporting process changes. Adhering to the mandatory industry regulation and compliance requirements for the given process, conducting Audit, Foresee Risk and institutionalizing necessary controls.6. Performing knowledge sharing, Update Process documentation /user manuals as appropriate for the process and Participating in knowledge transfer.7. Ensuring alignment to org driven metrics and hygiene needs in terms of Pyramid and Span, Job Rotation of resources and Cross Skilling of Resources.8. Mentoring /coaching and grooming teams members to grow, Driving teams learning and innovation index goals, Delegating, assigning and reviewing tasks given to team members for accuracy. Show less

• 

  Novo Nordisk

  Apr 2023 - now

  Associate Lead Data Manager